ACTRN12614000351617已完成3 期
Phase III Clinical Study of Allogeneic Stem CellTransplantation with Reduced Conditioning (RICT)versus Best Standard of Care in Acute Myeloid Leukemia(AML) in First Complete Remission
Australasian Leukaemia & Lymphoma Group (ALLG)0 个研究点目标入组 14 人开始时间: 2014年4月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 51 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. AML of intermediate or poor prognosis
- •2. Age 51 – 70 years.
- •3. Achieved CR1 or CRi.
- •4. Indication for a RIC but not a myeloablative alloSCT.
- •5. Judged to be able to tolerate a RICT if a suitable donor (MSD and/or MUD) is found.
- •6. Judged to be able to tolerate further standard consolidation chemotherapy.
- •7. Willing to undergo a RICT if a suitable donor is found.
- •8. Signed informed consent.
- •9. Willing and able to comply with protocol requirements.
- •10. Registration Form filled in and sent before initiation of donor search.
排除标准
- •1. AML with good risk features.
- •2. Planned to receive full dose conditioning.
- •3. Initiation of donor search performed before registration in the study.
- •4. Additional malignancy that might interact with the endpoints of the study.
- •5. Serum creatinine > 2 x the ULN, or abnormal liver function; ALT or AST > 3 x ULN.
- •6. Other severe concurrent illness.
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